In the past, oversight of image analysis was limited to the interpretation data by the reviewer. In this Guidance, the FDA clearly illustrates how many aspects of the process can affect the ultimate analysis.

The Guidance discusses many aspects of capturing and analyzing the images and how they can affect the final interpretation of the study results. If images are not captured consistently, then the interpretation can be compromised. If images are not collected at the correct timepoints, endpoints such as Progression Free Survival cannot be correctly identified. If images are not read by a trained reader who is unaware of the treatment and the stage of treatment, then bias can be introduced, which can ultimately affect trial integrity. Finally, if the correct aspects of the image are not identified consistently and correctly for analysis of endpoints, such as the RECIST score, then the results cannot be interpreted correctly.

Guidance documents like this contain process improvements that should be incorporated into the Risk Assessment process. For instance, after reading this guidance, processes may need to be modified to add a training aspect for the person interpreting the efficacy endpoint. Process oversight should confirm that the correct person completed the analysis and had the proper training and authority to do so. Minimizing the possibility of bias is another area that can be addressed as part of Risk Assessment. How will you minimize the risk, and how will you know if bias occurs?

Risk Based Monitoring was designed to help Sponsors, CROs, and Sites focus on the important aspects of trial conduct. This Guidance document reaffirms the FDA’s position on RBM to focus on specific processes, usually identified in the Risk Assessment, rather than merely conduct SDV. Assuring that primary endpoints are correctly collected by evaluating the processes used to minimize bias and assure the highest quality data takes time and effort, but ultimately is a better use of scarce oversight/monitoring resources.

For more information on MANA RBM’s Risk Assessment Service and how to integrate quality oversight and Risk Based Monitoring into your next trial, contact MANA RBM. 1-919-556-9456 or Dr. Manasco (pmanasco@manarbm.com).